Common use of Specific Training Clause in Contracts

Specific Training. GSK shall provide annual training to each Relevant Covered Person relating to his or her specific job responsibilities. This training shall be known as Specific Training. By December 31, 2012, each Relevant Covered Person engaged in Promotional Functions, Product Related Functions, or Payer Related Functions shall receive at least three hours of Specific Training in addition to the General Training required above. For Relevant Covered Persons engaged in Promotional Functions or Product Related Functions, this Specific Training shall include a discussion of: a. all applicable Federal health care program requirements relating to Promotional Functions and to Product Related Functions; b. all applicable FDA requirements relating to Promotional Functions and to Product Related Functions; c. all GSK Policies and Procedures and other requirements applicable to Promotional Functions and Product Related Functions; d. the personal obligation of each individual involved in Promotional Functions and Product Related Functions to comply with all applicable Federal health care program and FDA requirements and all other applicable legal requirements; e. the legal sanctions for violations of the applicable Federal health care program and FDA requirements; and f. examples of proper and improper practices related to Promotional Functions and Product Related Functions. For Relevant Covered Persons engaged in Payer Related Functions, this Specific Training shall include a discussion of topics a-f above, as well as: g. all applicable Federal health care program requirements and FDA requirements relating to Payer Related Functions; GlaxoSmithKline LLC Corporate Integrity Agreement h. GSK’s systems and processes applicable to Payer Related Functions; i. all GSK Policies and Procedures and other requirements applicable to Promotional Functions and Product Related Functions; j. the personal obligation of each individual involved in Payer Related Functions to ensure that all information provided or reported to Payers is complete, accurate and not misleading; k. the legal sanctions for violations of the applicable Federal health care program and FDA requirements; and l. examples of proper and improper practices relating to Payer Related Functions. New Relevant Covered Persons shall receive their Specific Training within 30 days after the beginning of their employment or becoming Relevant Covered Persons, or by December 31, 2012, whichever is later. A GSK employee who has completed the Specific Training shall oversee a new Relevant Covered Person’s work, to the extent that the work relates to any of the Covered Functions, until such time as the new Relevant Covered Person completes his or her Specific Training. After receiving the initial Specific Training described in this Section, each Relevant Covered Person shall receive at least three hours of Specific Training in each subsequent Reporting Period.

Specific Training. GSK Within 120 days after the Effective Date, J&J and/or the J&J Pharmaceutical Affiliates shall provide annual training at least three hours of Specific Training to each Relevant Covered Person relating to his or her specific job responsibilities. This training shall be known as Specific Training. By December 31, 2012, each Relevant Covered Person engaged in Promotional Functions, Product Related Functions, or Payer Related Functions shall receive at least three hours of Specific Training responsibilities in addition to the General Training required above. For Relevant Covered Persons engaged in Promotional Functions or Product Related Functions, this Specific Training shall include a discussion of: a. all applicable Federal health care program requirements relating to Promotional Functions and to Product Related Functions; b. all applicable FDA requirements relating to Promotional Functions and to Product Related Functions; c. all GSK applicable Policies and Procedures and other requirements applicable to Promotional Functions and Product Related Functions; d. the personal obligation of each individual involved in Promotional Functions and Product Related Functions to comply with all applicable Federal health care program and FDA requirements and all other applicable legal requirements; e. the legal sanctions for violations of the applicable Federal health care program and FDA requirements; and f. examples of proper and improper practices related to Promotional Functions and Product Related Functions. For Relevant Covered Persons engaged in Payer Managed Healthcare Related Functions, this Specific Training shall include a discussion of topics a-f above, as well as: g. all applicable Federal health care program requirements and FDA requirements relating to Payer Managed Healthcare Related Functions; GlaxoSmithKline LLC Corporate Integrity Agreement; h. GSK’s all company systems and processes applicable to Payer Managed Healthcare Related Functions; i. all GSK Policies and Procedures and other requirements applicable to Promotional Functions and Product Managed Healthcare Related Functions; j. the personal obligation of each individual involved in Payer Managed Healthcare Related Functions to ensure that all information provided or reported to Payers is complete, accurate and not misleading; k. the legal sanctions for violations of the applicable Federal health care program and FDA requirements; and l. examples of proper and improper practices relating to Payer Managed Healthcare Related Functions. New Relevant Covered Persons shall receive their Specific Training within 30 days after the beginning of their employment or becoming a Relevant Covered Persons, Person or by December 31, 2012within 120 days of the Effective Date, whichever is later. A GSK An employee of a J&J Pharmaceutical Affiliate who has completed the Specific Training shall oversee a new Relevant Covered Person’s work, to the extent that the work relates to any of the Covered Functions, until such time as the new Relevant Covered Person completes his or her Specific Training. The J&J Pharmaceutical Affiliates’ Relevant Covered Persons, who received Specific Training after January 1, 2013 explaining areas addressed in Section III.C.2.a-f. above are not required to receive additional specific training until the second Reporting Period. After receiving the initial Specific Training described in this Section, each Relevant Covered Person shall receive at least three hours of Specific Training in each subsequent Reporting Period.

Specific Training. GSK shall provide annual training to each Relevant Covered Person relating to his or her specific job responsibilities. This training shall be known as Specific Training. By December 31, 2012Within 120 days after the Effective Date, each Relevant Covered Person engaged in Promotional Functions, Product Related Functions, or Payer Related Government Contracting and Pricing Functions shall receive at least three four hours of Specific Training in addition to the General Training required above. For Relevant Covered Persons engaged in Promotional Functions or Product Related Functions, this This Specific Training shall include include, at a minimum, a discussion of: a. all applicable Federal health care program requirements relating to Government Pricing and Contracting Functions; b. all Biovail Policies and Procedures and other requirements applicable to Government Pricing and Contracting Functions; c. the personal obligation of each individual involved in Government Pricing and Contracting Functions to comply with all applicable Federal health care program requirements and all other applicable legal requirements; d. the legal sanctions for violations of the applicable Federal health care program requirements; and e. examples of proper and improper practices related to Government Pricing and Contracting Functions. Within 120 days after the Effective Date, each Relevant Covered Person engaged in Promotional and Product Services Related Functions (including BTA employees who have responsibilities managing or overseeing the PSS Contract) shall receive at least four hours of Specific Training in addition to the General Training required above. This Specific Training shall include, at a minimum, a discussion of: f. all applicable Federal health care program requirements relating to Promotional and to Product Services Related Functions; b. g. all applicable FDA requirements relating to Promotional Functions and to Product Services Related Functions; c. h. all GSK BiovaiI Policies and Procedures and other requirements applicable to Promotional Functions and Product Services Related Functions; d. i. the personal obligation of each individual involved in Promotional Functions and Product Services Related Functions to comply with all applicable Federal health care program and FDA requirements and all other applicable legal requirements; e. j. the legal sanctions for violations of the applicable Federal health care program and FDA requirements; and f. examples of proper and improper practices related to Promotional Functions and Product Related Functions. For Relevant Covered Persons engaged in Payer Related Functions, this Specific Training shall include a discussion of topics a-f above, as well as: g. all applicable Federal health care program requirements and FDA requirements relating to Payer Related Functions; GlaxoSmithKline LLC Corporate Integrity Agreement h. GSK’s systems and processes applicable to Payer Related Functions; i. all GSK Policies and Procedures and other requirements applicable to Promotional Functions and Product Related Functions; j. the personal obligation of each individual involved in Payer Related Functions to ensure that all information provided or reported to Payers is complete, accurate and not misleading; k. the legal sanctions for violations of the applicable Federal health care program and FDA requirements; and l. examples of proper and improper practices relating to Payer Promotional and Product Services Related Functions. To the extent that Biovail provided Specific Training to Relevant Covered Persons during the 180 days immediately prior to the Effective Date that satisfied the requirements set forth in this Section III.C.2 above, the OIG shall credit that training for purposes of satisfying Biovail’s Specific Training obligations of this Section III.C.2 for the first Reporting Period. New Relevant Covered Persons shall receive their Specific Training as set forth above within 30 days after the beginning of their employment or becoming Relevant Covered Persons, or by December 31, 2012within 120 days after the Effective Date, whichever is later. A GSK Biovail employee who has completed the Specific Training shall oversee review a new Relevant Covered Person’s work, to the extent that the work relates to any of the Covered Functions, Government Pricing and Contracting Functions or Promotional and Product Services Related Functions until such time as the new Relevant Covered Person completes his or her Specific Training. After receiving the initial Specific Training described in this Section, each Relevant Covered Person shall receive at least three hours of Specific Training in each subsequent Reporting Period.Period as defined in Section II.A.

Specific Training. GSK shall provide annual training to each Relevant Covered Person relating to his or her specific job responsibilities. This training shall be known as Specific Training. By December 31, 2012Within 90 days after the Effective Date, each Relevant Covered Person engaged in Promotional Functions, Product Related Functions, or Payer Related Government Contracting and Pricing Functions shall receive at least three two hours of Specific Training in addition to the General Training required above. For Relevant Covered Persons engaged in Promotional Functions or Product Related Functions, this This Specific Training shall include include, at a minimum, a discussion of: a. all applicable Federal health care program and FDA requirements relating to Promotional Functions Government Pricing and to Product Related Contracting Functions; b. all applicable FDA requirements relating to Promotional Functions and to Product Related Functions; c. all GSK Elan Policies and Procedures and other requirements applicable to Promotional Functions Government Pricing and Product Related Contracting Functions; d. c. the personal obligation of each individual involved in Promotional Government Pricing and Contracting Functions to comply with all applicable Federal health care program and Product FDA requirements and all other applicable legal requirements; d. the legal sanctions for violations of the applicable Federal health care program and FDA requirements; and e. examples of proper and improper practices related to Government Pricing and Contracting Functions. Within 90 days after the Effective Date, each Relevant Covered Person engaged in Medical Affairs and Materials Related Functions shall receive at least two hours of Specific Training in addition to the General Training required above. This Specific Training shall include, at a minimum, a discussion of: a. all applicable Federal health care program and FDA requirements relating to Medical Affairs and Materials Related Functions; b. all Elan Policies and Procedures and other requirements applicable to Medical Affairs and Materials Related Functions; c. the personal obligation of each individual involved in Medical Affairs and Materials Related Functions to comply with all applicable Federal health care program and FDA requirements and all other applicable legal requirements; e. d. the legal sanctions for violations of the applicable Federal health care program and FDA requirements; and f. e. examples of proper and improper practices related to Promotional Functions Medical Affairs and Product Related Functions. For Relevant Covered Persons engaged in Payer Related Functions, this Specific Training shall include a discussion of topics a-f above, as well as: g. all applicable Federal health care program requirements and FDA requirements relating to Payer Related Functions; GlaxoSmithKline LLC Corporate Integrity Agreement h. GSK’s systems and processes applicable to Payer Related Functions; i. all GSK Policies and Procedures and other requirements applicable to Promotional Functions and Product Related Functions; j. the personal obligation of each individual involved in Payer Related Functions to ensure that all information provided or reported to Payers is complete, accurate and not misleading; k. the legal sanctions for violations of the applicable Federal health care program and FDA requirements; and l. examples of proper and improper practices relating to Payer Materials Related Functions. New Relevant Covered Persons shall receive their Specific Training as set forth above within 30 days after the beginning of their employment or becoming Relevant Covered Persons, or by December 31, 2012within 90 days after the Effective Date, whichever is later. A GSK An Elan employee who has completed the Specific Training shall oversee review a new Relevant Covered Person’s work, to the extent that the work relates to any of the Covered Government Pricing and Contracting Functions or Medical Affairs and Materials Related Functions, until such time as the new Relevant Covered Person completes his or her Specific Training. After receiving the initial Specific Training described in this Section, each Relevant Covered Person shall receive at least three two hours of Specific Training in each subsequent Reporting Period.

Specific Training. GSK Amgen shall provide annual training to each Relevant Covered Person relating to his or her specific job responsibilities. This training shall be known as Specific Training. By December 31Amgen represents that all Relevant Covered Persons who engage in or supervise Covered Persons who engage in Payor Related Functions also are, 2012and will continue to be throughout the term of this CIA: (i) Relevant Covered Persons who engage in or supervise Covered Persons who engage in Promotional Functions; or (ii) Relevant Covered Persons who engage in or supervise Covered Persons who engage in Product Related Functions. Amgen further represents that Specific Training for Promotional Functions and Product Related Functions will address, throughout the term of this CIA, requirements for Payor Related Functions. Within 120 days after the Effective Date, each Relevant Covered Person engaged in Promotional Functions, Product Related Functions, or Payer Payor Related Functions shall receive at least three hours of Specific Training in addition to the General Training required above. For Relevant Covered Persons engaged in Promotional Functions or Product Related Functions, this This Specific Training shall include a discussion of: a. all applicable Federal health care program requirements relating to Promotional Functions and to Functions, Product Related Functions;, and Payor Related Functions; Corporate Integrity Agreement Amgen Inc. b. all applicable FDA requirements relating to Promotional Functions Functions, Product Related Functions, and to Product Payor Related Functions; c. all GSK Amgen Policies and Procedures and other requirements applicable to Promotional Functions Functions, Product Related Functions, and Product Payor Related Functions; d. Amgen’s systems and processes applicable to Payor Related Functions; e. the personal obligation of each individual involved in Promotional Functions Functions, Product Related Functions, and Product Payor Related Functions to comply with all applicable Federal health care program and FDA requirements and all other applicable legal requirements; e. f. the personal obligation of each individual involved in Payor Related Functions to ensure that all information provided or reported to Payors is complete, accurate, and not misleading; g. the legal sanctions for violations of the applicable Federal health care program and FDA requirements; and f. h. examples of proper and improper practices related Promotional Functions, Product Related Functions, and Payor Related Functions. Within 120 days after the Effective Date, each Relevant Covered Person engaged in Government Pricing Functions shall receive at least three hours of Specific Training in addition to the General Training required above. This Specific Training shall include a discussion of: i. Amgen’s systems and processes relating to Government Pricing Functions; Corporate Integrity Agreement Amgen Inc. j. all applicable Federal health care program requirements relating to Government Pricing Functions; k. Amgen’s systems for gathering relevant data and calculating, verifying, and reporting information to CMS and/or the State Medicaid Programs for purposes of the Medicaid Drug Rebate Program, the Medicare Program, or any other Federal or state government price reporting requirement; l. the personal obligation of each individual involved in Government Pricing Functions to ensure that all reported pricing and other information is accurate; m. the legal sanction for violations of Federal health care program requirements; and n. examples of proper and improper practices related to Promotional Functions and Product Related Functions. For Relevant Covered Persons engaged in Payer Related Functions, this Specific Training shall include a discussion of topics a-f above, as well as: g. all applicable Federal health care program requirements and FDA requirements relating to Payer Related Functions; GlaxoSmithKline LLC Corporate Integrity Agreement h. GSK’s systems and processes applicable to Payer Related Functions; i. all GSK Policies and Procedures and other requirements applicable to Promotional Functions and Product Related Functions; j. the personal obligation of each individual involved in Payer Related Functions to ensure that all information provided or reported to Payers is complete, accurate and not misleading; k. the legal sanctions for violations of the applicable Federal health care program and FDA requirements; and l. examples of proper and improper practices relating to Payer Related Government Pricing Functions. New Relevant Covered Persons shall receive their Specific Training within 30 days after the beginning of their employment or becoming Relevant Covered Persons, or by December 31, 2012within 120 days after the Effective Date, whichever is later. A GSK employee Covered Person who has completed the Specific Training shall oversee review the work of a new Relevant Covered Person’s work, to the extent that the work relates to any of the Covered Functions, until such time as the new Relevant Covered Person completes his or her Specific Training. After receiving the initial Specific Training described in this Section, each Relevant Covered Person shall receive at least three hours of Specific Training in each subsequent Reporting Period.